MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS; WASHER, BOLT, NUT

Model Number	TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a surgery tightrope hasn't flipped.Per complaint reporter there was no harm for patient, operator or third party.No further information was provided.

• Brand Name: TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
• Common Device Name: WASHER, BOLT, NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 25044267
• Report Number: 1220246-2026-02571
• Device Sequence Number: 9725722
• Product Code: HTN
• UDI-Device Identifier: 00888867352278
• UDI-Public: (01)00888867352278(11)251210(17)301130(10)15543146
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
• Device Catalogue Number: AR-8959TDS
• Device Lot Number: 15543146
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown